indomethacin (Rectal route)

NSAIDs cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. Indomethacin is contraindicated in the setting of CABG surgery. NSAIDs can also cause an increased risk of serious gastrointestinal (GI) adverse events, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at a greater risk for serious GI events .

Uses For indomethacin

Indomethacin is a nonsteroidal anti-inflammatory drug (NSAID) used to help relieve symptoms of moderate to severe arthritis (eg, osteoarthritis and rheumatoid arthritis) or gout, such as inflammation, swelling, stiffness, and joint pain. However, indomethacin does not cure arthritis and will help you only as long as you continue to use it.

Indomethacin is also used to treat moderate to severe ankylosing spondylitis, which is a type of arthritis that affects the joints in the spine. indomethacin may also be used to treat painful shoulder caused by bursitis or tendinitis.

indomethacin is available only with your doctor's prescription.

Before Using indomethacin

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For indomethacin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to indomethacin or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of indomethacin rectal suppositories in children up to 14 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of indomethacin rectal suppositories in the elderly. However, elderly patients may be more sensitive to the effects of indomethacin than younger adults, and are more likely to have unwanted effects (eg, stomach ulcers, confusion, psychosis) and age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving indomethacin rectal suppositories.

Pregnancy

Pregnancy Category

Explanation

1st Trimester

C

Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

2nd Trimester

C

Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

3rd Trimester

D

Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking indomethacin, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using indomethacin with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Ketorolac

Using indomethacin with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Abciximab

Aceclofenac

Acemetacin

Acenocoumarol

Amiloride

Amineptine

Amitriptyline

Amitriptylinoxide

Amoxapine

Amtolmetin Guacil

Anagrelide

Apixaban

Ardeparin

Argatroban

Aspirin

Balsalazide

Bemiparin

Bendroflumethiazide

Benzthiazide

Betamethasone

Betrixaban

Bismuth Subsalicylate

Bivalirudin

Bromfenac

Budesonide

Bufexamac

Bumetanide

Cangrelor

Celecoxib

Certoparin

Chlorothiazide

Chlorthalidone

Choline Magnesium Trisalicylate

Choline Salicylate

Cilostazol

Citalopram

Clomipramine

Clonixin

Clopamide

Clopidogrel

Cortisone

Cyclopenthiazide

Cyclosporine

Dabigatran Etexilate

Dalteparin

Danaparoid

Deflazacort

Desipramine

Desirudin

Desmopressin

Desvenlafaxine

Dexamethasone

Dexibuprofen

Dexketoprofen

Diazoxide

Dibenzepin

Diflunisal

Digoxin

Dipyridamole

Dipyrone

Dothiepin

Doxepin

Droxicam

Duloxetine

Edoxaban

Enoxaparin

Eplerenone

Epoprostenol

Eptifibatide

Escitalopram

Ethacrynic Acid

Etodolac

Etofenamate

Etoricoxib

Felbinac

Fenoprofen

Fepradinol

Feprazone

Feverfew

Floctafenine

Flufenamic Acid

Fluocortolone

Fluoxetine

Flurbiprofen

Fluvoxamine

Fondaparinux

Furosemide

Ginkgo

Gossypol

Heparin

Hydrochlorothiazide

Hydrocortisone

Hydroflumethiazide

Ibuprofen

Iloprost

Imipramine

Indapamide

Ketoprofen

Lepirudin

Levomilnacipran

Lithium

Lofepramine

Lornoxicam

Loxoprofen

Lumiracoxib

Magnesium Salicylate

Meadowsweet

Meclofenamate

Mefenamic Acid

Melitracen

Meloxicam

Mesalamine

Methotrexate

Methyclothiazide

Methylprednisolone

Metolazone

Milnacipran

Morniflumate

Nabumetone

Nadroparin

Naproxen

Nefazodone

Nepafenac

Niflumic Acid

Nimesulide

Nimesulide Beta Cyclodextrin

Nortriptyline

Olsalazine

Opipramol

Oxaprozin

Oxyphenbutazone

Paramethasone

Parecoxib

Parnaparin

Paroxetine

Pemetrexed

Pentosan Polysulfate Sodium

Pentoxifylline

Phenindione

Phenprocoumon

Phenylbutazone

Phenyl Salicylate

Piketoprofen

Piroxicam

Polythiazide

Potassium

Pralatrexate

Prasugrel

Prednisolone

Prednisone

Probenecid

Proglumetacin

Propyphenazone

Proquazone

Protein C

Protriptyline

Reboxetine

Reviparin

Rivaroxaban

Rofecoxib

Salicylamide

Salicylic Acid

Salsalate

Sertraline

Sibutramine

Sodium Salicylate

Spironolactone

Sulfasalazine

Sulindac

Tacrolimus

Tenoxicam

Tianeptine

Tiaprofenic Acid

Ticagrelor

Ticlopidine

Tinzaparin

Tirofiban

Tolfenamic Acid

Tolmetin

Torsemide

Treprostinil

Triamterene

Trichlormethiazide

Trimipramine

Trolamine Salicylate

Valdecoxib

Vasopressin

Venlafaxine

Vilazodone

Vorapaxar

Vortioxetine

Warfarin

Xipamide

Using indomethacin with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acebutolol

Alacepril

Atenolol

Azilsartan

Azilsartan Medoxomil

Benazepril

Betaxolol

Bisoprolol

Candesartan

Captopril

Carteolol

Carvedilol

Celiprolol

Cilazapril

Delapril

Enalapril

Enalaprilat

Eprosartan

Esmolol

Fosinopril

Gentamicin

Imidapril

Irbesartan

Labetalol

Levobunolol

Lisinopril

Losartan

Metipranolol

Metoprolol

Moexipril

Nadolol

Nebivolol

Olmesartan

Oxprenolol

Penbutolol

Pentopril

Perindopril

Pindolol

Practolol

Propranolol

Quinapril

Ramipril

Sotalol

Spirapril

Telmisartan

Temocapril

Timolol

Trandolapril

Valsartan

Zofenopril

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of indomethacin. Make sure you tell your doctor if you have any other medical problems, especially:

Anemia or

Bleeding problems or

Blood clots or

Depression or other mental changes or

Edema (fluid retention or body swelling) or

Heart attack, recent or history of or

Heart disease (eg, congestive heart failure) or

Hepatitis or jaundice, history of or

Hyperkalemia (high potassium in the blood) or

Hypertension (high blood pressure) or

Kidney disease or

Liver disease or

Parkinsonism or

Seizures or epilepsy, history of or

Stomach ulcers or bleeding, history of or

Stroke, history of—Use with caution. May make these conditions worse.

Aspirin-sensitive asthma, history of or

Aspirin sensitivity, history of or

Proctitis (inflammation of the rectum), history of or

Rectal bleeding, recent—Should not be used in patients with these conditions.

Heart surgery (eg, coronary artery bypass graft [CABG] surgery)—Should not be used to relieve pain right before or after the surgery.

Proper Use of indomethacin

For safe and effective use of indomethacin, do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. Using too much of indomethacin may increase the chance of unwanted effects.

indomethacin should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

When used for severe or continuing arthritis, indomethacin must be used regularly as ordered by your doctor in order for it to help you. indomethacin usually begins to work within one week, but in severe cases up to two weeks or even longer may pass before you begin to feel better. Also, several weeks may pass before you feel the full effects of indomethacin.

Do not take rectal suppositories by mouth or use it in the vagina.

To use the suppository:

If the suppository is too soft to insert, chill it in the refrigerator for 30 minutes or run cold water over it before removing the foil wrapper.

Remove the foil wrapper and moisten the suppository with cold water.

Lie down on your side and use your finger to push the suppository well up into the rectum

Remain lying down for about 15 minutes to keep the suppository from coming out before it melts.

Make sure to wash your hands with soap and water before and after inserting indomethacin.

Dosing

The dose of indomethacin will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of indomethacin. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For rectal dosage form (suppositories):

For moderate to severe ankylosing spondylitis, osteoarthritis, or rheumatoid arthritis:

Adults and children older than 14 years of age—One 50-milligram (mg) suppository, inserted into the rectum up to 3 times a day.

Children up to 14 years of age—Use and dose must be determined by your doctor.

For acute painful shoulder caused by bursitis or tendinitis:

Adults and children older than 14 years of age—One suppository inserted into the rectum 3 to 4 times a day.

Children up to 14 years of age—Use and dose must be determined by your doctor.

For gout:

Adults and children older than 14 years of age—One suppository inserted into the rectum 3 times a day.

Children up to 14 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of indomethacin, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using indomethacin

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to use it. Blood and urine tests may be needed to check for unwanted effects.

indomethacin may increase your risk of having a heart attack or stroke. This is more likely in people who already have heart disease. People who use indomethacin for a long time might also have a higher risk.

indomethacin may cause bleeding in your stomach or intestines. These problems can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, are over 60 years of age, are in poor health, or are using certain other medicines (such as a steroid medicine or a blood thinner).

Serious skin reactions can occur during treatment with indomethacin. Check with your doctor right away if you have any of the following symptoms while using indomethacin: blistering, peeling, loosening of the skin, chills, cough, diarrhea, fever, itching, joint or muscle pain, red skin lesions, sore throat, sores, ulcers, white spots in the mouth or on the lips, or unusual tiredness or weakness.

Some possible warning signs of serious side effects that can occur during treatment with indomethacin may include black, tarry stools, decreased urination, severe stomach pain, skin rash, swelling of the face, fingers, feet, or lower legs, unusual bleeding or bruising, unusual weight gain, vomiting of blood or material that looks like coffee grounds, or yellow skin or eyes. Also, signs of serious heart problems could occur, such as chest pain, tightness in chest, fast or irregular heartbeat, unusual flushing or warmth of the skin, weakness, or slurring of speech. Stop using indomethacin and check with your doctor right away if you notice any of these warning signs.

indomethacin may also cause a serious type of allergic reaction called anaphylaxis. Although this is rare, it may occur more often in patients who are allergic to aspirin or to any of the nonsteroidal anti-inflammatory drugs (NSAIDs). Anaphylaxis can be life-threatening and requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, or fainting. Other signs may include changes in color of the skin of the face, very fast but irregular heartbeat or pulse, hive-like swellings on the skin, and puffiness or swellings of the eyelids or around the eyes. If these effects occur, get emergency help at once.

Using indomethacin during the later part of a pregnancy can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.

indomethacin may cause a delay in ovulation for women and may affect their ability to have children. If you plan to have children, talk with your doctor before using indomethacin.

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

indomethacin may cause some people to become dizzy, lightheaded, drowsy, or less alert than they are normally. Even if used at bedtime, it may cause some people to feel drowsy or less alert on arising. Make sure you know how you react to indomethacin before you drive, use machines, or do anything else that could be dangerous if you are not alert.

Before having any kind of surgery or medical tests, tell your doctor that you are using indomethacin. It may be necessary for you to stop treatment for a while, or to change to a different nonsteroidal anti-inflammatory drug before your procedure.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements. .

indomethacin Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

red skin lesions, often with a purple center

red, irritated eyes

red, swollen skin

redness of the face, neck, arms and occasionally, upper chest

scaly skin

seeing double

seeing, hearing, or feeling things that are not there

seizures

sense of detachment from self or body

severe constipation

severe mental changes

severe or continuing stomach pain

shuffling walk

slow, fast, irregular, pounding, or racing heartbeat or pulse

slowed movements

slurred speech

small red or purple spots on the skin

sore throat

sores, ulcers, or white spots on the lips or tongue or inside the mouth

stiffness of the arms and legs

sudden loss of consciousness

swelling in the legs and ankles

swelling of the face, fingers, feet, or lower legs

swelling of the breasts or breast soreness in both females and males

swollen or painful glands

tightness in the chest

trembling and shaking of the fingers and hands

troubled breathing at rest

troubled breathing with exertion

unexplained weight loss

unpleasant breath odor

unsteadiness or awkwardness

unusual bleeding or bruising

unusual tiredness or weakness

vaginal bleeding

vomiting of blood or material that looks like coffee grounds

weakness in the arms, hands, legs, or feet

weight gain

yellow eyes or skin

Incidence not known

Frequent urge to defecate

rectal bleeding, burning, dryness, itching, or pain

straining while passing stool

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Confusion about identity, place, and time

severe headache

unusual drowsiness, dullness, or feeling of sluggishness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Mild headache

Less common

Continuing ringing or buzzing or other unexplained noise in the ears

difficulty having a bowel movement (stool)

discouragement

feeling sad or empty

general feeling of discomfort or illness

hearing loss

irritability

loss of interest or pleasure

sleepiness

trouble with concentrating

Rare

Anxiety

bloated full feeling

changes in patterns and rhythms of speech

excess air or gas in the stomach or intestines

feeling of constant movement of self or surroundings

involuntary muscle movements

lightheadedness

passing gas

sensation of spinning

tiredness

trouble with speaking

trouble sleeping

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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